Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Recruiting · NCT04956016 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Henri Laborit
View the official record on ClinicalTrials.gov →Interventions studied
classic rTMS using the 8-shaped coildeep rTMS using the H1-shaped coil
What this trial is about
The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies. 20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Volunteer subjects over 18 years old
- Having signed a free and informed consent
- Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
- Having an antidepressant treatment not modified since 3 weeks
- Score to MADRS scale ≥ 21
- Subject affiliated to a social security regimen
Exclusion criteria
- Depression with psychotic caracteristics
- Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
- Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
- Patient hospitalized under duress or under legal protection (guardianship, curatorship)
- Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization.
- Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
- Pregnancy
- Simultaneous participation to another interventionnal study
Where it is running
1 location listed.
- Centre Hospitalier Henri Laborit - Poitiers, France